The 2nd UMBC–Stanford Workshop
on Clinical Trials and Regulatory Science

Event Summary: A one-day workshop organized by the Center for Interdisciplinary Research and Consulting at the University of Maryland, Baltimore County (UMBC), and the Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.

Registration is now closed

⇒View Archives here⇐

Organizing Committee:

Faculty from UMBC and Stanford University and leaders from FDA and industry.

For more information: Please contact Dr. Yi Huang, Department of Mathematics and Statistics, University of Maryland Baltimore County (UMBC), 1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.

For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.


Participant Information

Tai-Tsang Chen from BMS.

Paper: Monitoring Late-Stage Randomized Clinical Trials with Cancer Immunotherapy

The new class of immuno-oncology agents has shown some unique survival kinetics including long-term survival in a proportion of treated patients. Even if this phenomenon is accounted for in the study design, a misspecification of the long-term survival rate could pose challenges in the study conduct for the event-driven studies. A monitoring approach was proposed to inform decisions on better resource and logistic planning with quantifiable risks.


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